Examining the Feasibility of Wysa in Hindi

NCT06320756 | Completed

• 1 other identifier: 24-WYSA-101
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

The principal objective of this study is to investigate the feasibility of including a digital mental health intervention (Wysa in Hindi) within pre-existing usual care to support adolescents and young adults with Type 1 Diabetes (T1D) who have mild and above mental health distress (operationalized as Patient Health Questionnaire-9: 5-14 scores; or Diabetes Distress Scale-17: \>2.0 mean score) with their mental health distress. This will be conducted through an exploratory randomized control study comparing Wysa in Hindi plus usual care with a control arm that just has usual care. The study further explores the effectiveness of the digital mental health intervention using the Patient Health Questionnaire (PHQ-9) and Diabetes Distress Scale (DDS-17).

Conditions

Mental Health Issue; Diabetes Distress

Keywords

digital mental health

Outcome Measures

Primary Outcomes (6)

• Feasibility - Recruitment rate (Proportion of participants who completed consent procedures)

  Proportion of participants who completed consent procedures versus those who were invited to participate in the study via awareness activities.

  Measured at the end of the recruitment period (3 weeks, or if recruitment is extended at the end of 2 months)

• Feasibility - Retention rate (Proportion of participants who remained enrolled within the study for the entire study duration)

  Proportion of recruited participants who completed endline assessments i.e. those who remained enrolled for the study duration.

  Measured after the 2 month intervention during follow-up endline assessments

• Feasibility - Wysa Engagement (Proportion of recruited participants who engaged in at least 1 interaction with the Wysa app)

  Proportion of recruited participants who interacted with Wysa at least once after onboarding to the app. Information will also collected on average numbers of days the app was used.

  Measured at the end of the 2 month intervention

• Feasibility - App therapist engagement rate (Proportion of recruited participants who completed at least one therapist session within the Wysa app)

  Proportion of recruited participants who completed at least one session with the therapist available on Wysa app.

  Measured at the end of the 2 month intervention

• Satisfaction with the app which is collected through 3 quantitative questions and 1 free text qualitative question on the app

  Feedback is collected through 4 questions wherein 3 questions ask participants to provide a quantitative rating of the app features' usability and satisfaction. Participants can provide ratings on a 5 point likert scale with higher ratings denoting higher satisfaction. 1 qualitative question invites participant to use free text format to provide any additional feedback. All feedback is collected twice on the app i..e. Day 2 and Day 45 from onboarding.

  This is collected twice; on day 2 and day 45 from onboarding on the app

• Therapist Satisfaction feedback collected through 3 quantitative questions and 1 free text qualitative question on the app

  Participants provide feedback about their app therapist sessions through 3 questions asking for a quantitative rating of their satisfaction, and 1 question where participant can provide a free text response with their overall feedback. The quantitative rating is on a 5 point Likert scale with higher ratings indicating higher satisfaction. Feedback will be collected at the end of each therapist session.

  Collected post every therapist session during the intervention period of 2 months

Secondary Outcomes (2)

• Change in mental health distress as measured by the Patient Health Questionnaire (PHQ-9)

  Baseline assessment, and then at the 2 month follow-up endline assessment

• Change in mental health distress as measured by the Diabetes Distress Scale (DDS-17)

  Baseline assessment, and then at the 2 month follow up assessment

Study Arms (2)

Intervention arm: Wysa in Hindi + usual care

EXPERIMENTAL

The intervention arm will receive Wysa in Hindi and the usual care. Wysa in Hindi is a digital mental health intervention that combines Artificial Intelligence-led conversational chatbot support and human therapy in the Hindi language. The Artificial Intelligence (AI) chatbot acts as a companion, and understands, empathizes, and guides users through exercises grounded in cognitive behavioral therapy (CBT) techniques, written by qualified psychologists and clinicians. Usual care includes access to individual and bi-weekly group sessions focused on building coping, wellbeing, and motivation by the diabetes educator team.

Behavioral: Wysa in Hindi; Behavioral: Individual and group sessions on topics like motivation, coping, wellbeing

Usual care arm

ACTIVE COMPARATOR

Participants in the control group will only have access to usual care (which will remain the same as that for the intervention arm). This includes access to individual sessions and bi-weekly group sessions with the diabetes education team on motivation, wellbeing, and coping.

Behavioral: Individual and group sessions on topics like motivation, coping, wellbeing

Interventions

Wysa in Hindi BEHAVIORAL

Wysa in Hindi is a blended digital mental health intervention

Intervention arm: Wysa in Hindi + usual care

Individual and group sessions on topics like motivation, coping, wellbeing BEHAVIORAL

Individual and group sessions on wellbeing, coping, and motivation with the diabetes educator team

Intervention arm: Wysa in Hindi + usual care; Usual care arm

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 13-25 years
• Diagnosis of Type1 diabetes
• Access to a smartphone with internet connection
• Can read and understand Hindi
• Mental health distress as demonstrated by elevated scores on any of the scales: Mild -moderate symptoms (between 5-14 score) on Patient Health Questionnaire (PHQ-9), moderate and above diabetes distress (mean score 2.0 and higher) on the Diabetes Distress Scale (DDS-17)

You may not qualify if:

• Do not own or have access to a mobile device
• Are identified to have risk of harm/ suicidality (as identified on PHQ-9)
• Are currently undergoing or have received psychiatric support
• Experience any mental or physical impairments that create accessibility barriers to the use of a smartphone or access to a digital mental health intervention

Sponsors & Collaborators

• Wysa: lead
• Udaan: collaborator

Study Sites (1)

Udaan

Aurangabad, Maharashtra, 431003, India

Location

Related Publications (2)

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626.

  PMID: 15735199 BACKGROUND

MeSH Terms

Interventions

Coping Skills; Health

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Population Characteristics

Study Officials

• Tejaswi Shetty, M.A.

  Touchkin eServices Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

• Archana Sarda, M.D

  Udaan

  PRINCIPAL INVESTIGATOR

• Chaitali Sinha, M.A.

  Touchkin eServices Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized Control Trial with an intervention arm and a control arm.

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 20, 2024
• Study Start: February 23, 2024
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)